ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler micro labs limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-137
Product ID 42571-137_3febb42b-8d54-b958-e063-6394a90acea3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203410
Listing Expiration 2026-12-31
Marketing Start 2019-06-03

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitor [epc] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571137
Hyphenated Format 42571-137

Supplemental Identifiers

RxCUI
860107
UPC
0342571137311
UNII
4EVE5946BQ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ketorolac tromethamine (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number ANDA203410 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (42571-137-25)
  • 10 mL in 1 BOTTLE (42571-137-26)
  • 3 mL in 1 BOTTLE (42571-137-31)
source: ndc

Packages (3)

42571-137-25 5 mL in 1 BOTTLE (42571-137-25) 42571-137-26 10 mL in 1 BOTTLE (42571-137-26) 42571-137-31 3 mL in 1 BOTTLE (42571-137-31)

Ingredients (1)

ketorolac tromethamine (5 mg/mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3febb42b-8d54-b958-e063-6394a90acea3", "openfda": {"upc": ["0342571137311"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["631c2c31-cd4f-4a17-85c6-be96746a753e"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (42571-137-25)", "package_ndc": "42571-137-25", "marketing_start_date": "20190603"}, {"sample": false, "description": "10 mL in 1 BOTTLE (42571-137-26)", "package_ndc": "42571-137-26", "marketing_start_date": "20190603"}, {"sample": false, "description": "3 mL in 1 BOTTLE (42571-137-31)", "package_ndc": "42571-137-31", "marketing_start_date": "20190603"}], "brand_name": "Ketorolac Tromethamine", "product_id": "42571-137_3febb42b-8d54-b958-e063-6394a90acea3", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42571-137", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA203410", "marketing_category": "ANDA", "marketing_start_date": "20190603", "listing_expiration_date": "20261231"}